Tacrolimus, Sirolimus and Methotrexate as Graft Versus Host Disease Prophylaxis After Blood Stem Cell Transplantation
This study has been completed.
Sponsor:
Dana-Farber Cancer Institute
Collaborators:
Brigham and Women's Hospital
Beth Israel Deaconess Medical Center
Massachusetts General Hospital
Information provided by (Responsible Party):
Edwin P. Alyea, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00146614
First received: September 6, 2005
Last updated: March 6, 2012
Last verified: March 2012
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Purpose
The purpose of this study is to determine if the incidence of Graft vs. Host Disease (GVHD) after non-myeloablative transplantation can be reduced by using a combination of three immune suppressive medication; sirolimus, tacrolimus and methotrexate.
| Condition | Intervention | Phase |
|---|---|---|
|
Graft Versus Host Disease Hematologic Malignancies |
Drug: Sirolimus Drug: Tacrolimus Drug: Methotrexate Procedure: Stem Cell Transplantation |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Tacrolimus, Sirolimus and Methotrexate as Graft Versus Host Disease Prophylaxis After Allogeneic Non-Myeloablative Peripheral Blood Stem Cell Transplantation |
Resource links provided by NLM:
Drug Information available for:
Methotrexate
Methotrexate sodium
Sirolimus
Tacrolimus
Everolimus
Temsirolimus
U.S. FDA Resources
Further study details as provided by Dana-Farber Cancer Institute:
Primary Outcome Measures:
- To assess the effect on the incidence and severity of GVHD by adding sirolimus, tacrolimus and methotrexate to GVHD prophylaxis.
| Estimated Enrollment: | 105 |
| Study Start Date: | July 2002 |
| Study Completion Date: | April 2003 |
| Primary Completion Date: | April 2003 (Final data collection date for primary outcome measure) |
- Patients will be admitted to the hospital and receive chemotherapy and stem cell transplant(SCT). The total duration of hospitalization for the procedure is approximately 8 days. Once admitted the patient will receive fludarabine daily for 4 days, busulfex once daily for 4 days. Two days after chemotherapy has ended, the patient will receive the infusion of donor cells.
- Just prior to the transplant and following the transplant, patients will receive sirolimus (orally), tacrolimus (orally) and low doses of methotrexate (chemotherapy). Methotrexate will be given on days 1,3 and 6 after transplant.
- Sirolimus will be tapered beginning week 9 after transplant if there is no evidence of GVHD and will be eliminated on week 26 if clinically feasible.
- Tacrolimus will be tapered beginning week 9 after transplant if there is no evidence of GVHD and will be eliminated on week 26 if clinically feasible.
- Patients will also receive medication to help prevent possible infection.
- After stem cell infusion, patients will be examined and have blood tests weekly for 1 month. At the 1 month visit, a bone marrow biopsy will performed looking for evidence of donor cells in the bone marrow. After the one month evaluation the patient will be examined every 2 weeks and a repeat bone marrow performed 3-4 months after transplant.
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients with hematologic malignancies who are at a high risk of complications after conventional transplantation.
- Donors (both related and unrelated) who are identical at 6 HLA loci.
- Age greater than 18
- ECOG Performance Status 0-2
- Life expectancy of greater than 100 days.
Exclusion Criteria:
- Pregnancy
- Evidence of HIV infection
- Heart failure uncontrolled by medications
- Total Bilirubin > 2.0mg/dl due to hepatocellular dysfunction
- AST > 90
- Serum creatinine > 2.0
- Cholesterol > 300 mg/dl
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00146614
Please refer to this study by its ClinicalTrials.gov identifier: NCT00146614
Locations
| United States, Massachusetts | |
| Beth Isreal Deaconess Medical Center | |
| Boston, Massachusetts, United States, 02115 | |
| Dana-Farber Cancer Institute | |
| Boston, Massachusetts, United States, 02115 | |
| Massachusetts General Hospital | |
| Boston, Massachusetts, United States, 02115 | |
Sponsors and Collaborators
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Beth Israel Deaconess Medical Center
Massachusetts General Hospital
Investigators
| Principal Investigator: | Edwin P. Alyea, MD | Dana-Farber Cancer Institute |
More Information
| Responsible Party: | Edwin P. Alyea, MD, Principal Investigator, Dana-Farber Cancer Institute |
| ClinicalTrials.gov Identifier: | NCT00146614 History of Changes |
| Other Study ID Numbers: | 02-057 |
| Study First Received: | September 6, 2005 |
| Last Updated: | March 6, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Dana-Farber Cancer Institute:
|
Graft versus Host Disease GVHD Stem Cell Transplantation Tacrolimus |
Sirolimus Methotrexate allogeneic stem cell transplantation |
Additional relevant MeSH terms:
|
Graft vs Host Disease Immune System Diseases Methotrexate Tacrolimus Sirolimus Everolimus Abortifacient Agents, Nonsteroidal Abortifacient Agents Reproductive Control Agents Physiological Effects of Drugs Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action |
Antineoplastic Agents Dermatologic Agents Enzyme Inhibitors Folic Acid Antagonists Immunosuppressive Agents Immunologic Factors Antirheumatic Agents Nucleic Acid Synthesis Inhibitors Calcineurin Inhibitors Anti-Bacterial Agents Anti-Infective Agents Antibiotics, Antineoplastic Antifungal Agents |
ClinicalTrials.gov processed this record on September 23, 2016